ANZCTR search results

Around 30% of deaths at the Royal Adelaide Hospital (300 per annum) occur in the ICU or shortly after leaving ICU. The importance of reviewing end-of-life care in the ICU is well recognised. Benefits include assisting family members to process their grief and the opportunity to improve the care delivered to dying patients. Primary aim of this study is to establish the feasibility of delivering a bereavement service by the intensive care unit. Secondary aims are to assess the value of feedback received about the end-of-life care and how the service is viewed by family members. This is a prospective, observational study. All family representatives of patients who die in ICU are included in the study. They are excluded if a family representative is not contactable or declines participation.. Patients are referred to the bereavement follow-up service at medical consensus of end-of-life. After the patient's death, the appropriate family representative will be given a brochure providing bereavement information and a letter outlining the follow-up service. The 30 minute interview is based on the validated CAESAR tool, focused on care around the end-of-life. The responses will be recorded as Likert scores with the option to provide qualitative feedback. The bereavement calls will be made at 4 weeks, by clinicians who are experienced intensive care clinicians. The telephone interview questionnaire consists of 16 questions in 4 sections. The first section of the questionnaire relates to the care of the patient and support for the family. The second section relates to the communication between ICU and the family. The care of the patient and the discussion around organ donation are covered in the next two sections. The last section consists of open-ended question relating to how the family member feel the end-of-life care can be improved.

Patients who present for elective/non-emergent electrical cardioversion for atrial arrhythmias require sedation for the procedure. A combination of drugs, often including midazolam, a sedative that causes respiratory depression, is typically used. We hypothesise that removing midazolam from the combination of drugs used will result in a lower need for airway and breathing rescue techniques, without increasing patient's memory for the cardioversion procedure.

This study is designed to test the potential activity/benefit, safety and feasibility of adding a drug commonly used for bone protection (denosumab) to an immunotherapy drug (nivolumab) before surgery in patients with non-small cell lung cancer (NSCLC) for whom surgery has been recommended. Who is it for? You may be eligible for this study if you are aged 18 years or above and have a confirmed non-small cell lung cancer (NSCLC) for which surgery has been recommended to remove the cancer. Study details Participants will be randomly allocated (by chance) into one of two groups: in group 1, participants will receive two doses of nivolumab in the month prior to surgery, and in group 2, participants will receive two doses of denosumab in addition to the two doses of nivolumab in the month prior to surgery. Nivolumab is administered intravenously (i.e. directly into the vein) and denosumab is administered subcutaneously (i.e. as in injection under the skin). All participants will then proceed to surgery as planned. After surgery, no further trial medications are offered, but participants may be offered standard therapies according to the opinion of their treating clinicians. Those patients who receive denosumab will also be asked to take vitamin D and calcium supplementation during the course of their denosumab treatment. It is hoped this study will confirm that two doses of nivolumab prior to lung cancer surgery results in significant rates of tumour shrinkage similar to a previous USA study, and that denosumab added to nivolumab may show evidence of better effectiveness.

The study is a randomised, placebo-controlled, double-blind trial. Participants aged 40-70 with pre-diabetes (as per HbA1c) will be invited to participate through GP Practices involved in the diabetes alliance. Participants will be randomly allocated on a ratio1:1, to receive zinc or control treatment options, and followed up at one month, three months, six months and twelve months. Both treatment arms will have Get Healthy Information and Coaching Service, type 2 diabetes Prevention Program involved in their care for the first six months of the trial.

The purpose of the study is to provide a real world view of clinical practice, patient outcomes, safety, and the comparative effectiveness of SIR-Spheres treatment in patients with liver cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or over and Y90 therapy for the first time as treatment for either primary or secondary liver cancer. Study details The treatment is for primary and secondary liver cancer. The Radiation-Emitting SIR-Spheres In Non-resectable (RESIN) Liver Tumor involves patients with primary and secondary liver cancer receiving (Y90 resin microspheres) treatment as part of their overall oncologic management. The microsphere are injected into the liver through a blood vessel. This allows a large dose of radiation to be delivered to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. All visits and procedures related to SIR-Spheres treatment are performed on an outpatient basis per standard of care. Prior to treatment, patients are assessed by physical examination, radiographic evaluation, and blood tests to determine the health of the patient and liver. Standard of care tests done before this procedure may include: • physical exam and medical history • blood tests requiring about 2 tablespoons of blood • a chest x-ray, CT or MRI scan • an imaging scan (CT or MRI scan) of the liver Patients undergo an initial mapping arteriogram, to determine the distribution of blood vessels to the tumor(s), identify possible vessels which are to be avoided due to supply to the stomach/small bowel, and evaluate the amount of shunting through the tumor(s) to the lungs. This procedure is performed under sterile conditions with patients having a small tube (catheter) inserted through the skin. It is usually inserted into the thigh, into a blood vessel going to the liver. Depending on the size and location of tumors, there may be more than one treatment with SIR-Spheres planned. Repeat treatment is done between 4-8 weeks after the first treatment if there is more disease to treat.

The purpose of the CATCHER-1 study is to assess the usefulness of a blood test called Colvera in patients with bowel cancer over time. Colvera may provide information about the progress of bowel cancer and help to determine if a cancer treatment is working. When bowel cancer has spread to other organs or parts of the body (for example, liver, lung and the lining of the abdomen), this is known as advanced or metastatic bowel caner. Patients with advanced bowel cancer are generally treated with different types of drug therapy (systemic therapy) with the aim to control the cancer, slow its growth and manage symptoms. To monitor if systemic therapies are effective or not, patients undergo regular CT scans and often a blood test called CEA. However, sometimes, it can time for changes to become noticeable on CT, such that the images may not reflect a patient’s true clinical state. CEA, used alone, can have variable results. Who is it for? You may be eligible for this study if you are an adult who is commencing a new cancer treatment. Study details Colvera is designed to identify small amounts of altered DNA which may leak from a tumor into the bloodstream, called circulating tumor DNA or ctDNA. Colvera detects the presence or absence of two genes in ctDNA, (BCAT1 and IKZF1), that are often associated with colorectal cancer growth. While Colvera detects changes found in most advanced bowel cancers , Colvera may not be detectable in all patients. In this study, patients who are starting a new drug treatment for advanced bowel cancer, will undergo additional blood sampling for Colvera and CEA in addition to planned treatment. Your doctor remains in control of your care and this study will not impact on the standard of care you receive. The study is designed to monitor your care to evaluate if the level of Colvera in the blood is an effective marker in advanced bowel cancer, including in comparison with standard measures (CT scan and CEA). It is hoped that this research will determine whether Colvera is an effective way of determining whether treatment is effective, and if it is, will provide a more accurate way of guiding treatment in those with colorectal cancer

People who work out of synchronisation with their body clock e.g shift workers face higher rates of chronic diseases such as type 2 diabetes and cardiovascular disease. Eating at night time may contribute to this increased risk by forcing the body to break down and process food at a time usually associated with sleeping. Consuming the same meal at night time compared to the morning is associated with glucose intolerance, insulin resistance and changes in the expression of circadian genes. We hypothesise that altering the type of food consumed at night time may help modify these metabolic risks. In this study we aim to investigate the impact of two isocaloric meals differing in macronutrient composition on glucose and lipid homeostasis and expression of circadian genes in men with high fasting lipids kept awake overnight.

This study aims to identify risk factors for a deterioration in thinking and memory skills after a type of heart procedure known as transcatheter aortic valve implantation (TAVI). These changes may be short-term (such as delirium) or long-term cognitive decline. There will be 100 participants undergoing TAVI and 100 age-matched controls. Another part of this study will compare the 100 participants undergoing TAVI and the 100 control participants before the TAVI procedure i.e. the baseline data. This analysis will identify if participants with aortic stenosis compared with participants without aortic stenosis have different motor symptoms (walking, eye movement, voice, swallowing), mood, behaviour, brain activity (measured non-invasively using electroencephalogram or EEG), and their genotype taken from a saliva sample (with consent from participants).

This is a Phase I, open-label, single arm, long term follow up study to assess safety of ATX-101 in subjects with advanced solid tumours over a maximum period of 12 months. Who is it for? You may be eligible to join this study if you have completed participation in the preceding study AM ATX101-01. Study details The study is designed to systematically assess safety and tolerability of an additional 12 months of treatment with ATX-101, and to further investigate the exploratory pharmacodynamics (PD; biomarker analyses) and preliminary efficacy of ATX-101 (anti-tumour activity and maintenance of non-progressive disease status). Willing subjects must provide voluntary written informed consent prior to undergoing any further procedures to determine study eligibility. Screening evaluations will ensure that potential study subjects fulfil all requirements for entry into the long term follow up study. Up to 36 study subjects who have been exposed to ATX-101 in AM ATX101-01 will be enrolled. ATX-101 treatment will be administered weekly in cycles of 21-day duration, with a single IV infusion of ATX-101 on Day 1, 8 and 15 (± 3 days) of each cycle for up to 12 months, unless criteria for early termination is met. Prior to each infusion subjects will receive mandated premedication with corticosteroid and H1 and H2 inhibitors.

Impaired motor function and cognitive confusion are the most common diagnostic symptoms associated with "stroke". Few acute clinical investigations of visual function are conducted even though far greater volumes of cortical and subcortical regions of the brain are directly involved with visual functions than with motor function. Van Essen et al (1984) first highlighted the vast number of visual areas and volume of cortex attributed to visual sensory processing, visual attention, visuo-motor functions and visually driven emotional processing. Furthermore the eye and the brain share similar embryonically derived vascular tissues and blood flow making vision defect a likely companion to a brain blood disorder (stroke). Over the last decade Rowe et al (2009), Spotfforth et al (2017) and Quinn et al (2018) have described significant persistent visual deficits following stroke. Of those affected common visual deficits up to a year later include visual field loss (hemianopia, quadrantanopia) ,perceptual disorders (visual inattention/neglect) and eye movement disorders. Rowe et al (2009) also noted the large proportion of ocular alignment deficits co-morbid with visual field defects. Most recently Quinn et al (2018) highlighted the incidence of visual field deficits with coexisting visual neglect in post stroke survivors. Hemifield neglect has long been known as a perceptual deficit sometimes associated with stroke although when tested it is most often tested manually by line bisection or star cancellation even though stroke itself is usually defined by motor impairments. Application of sophisticated visual field analyzers such as the Humphrey have seldom been utilized in hospitalized stroke patients given that most cases involve elderly patients limited in mobility and who suffer motor impairment for at least 24 hours. Thus the purpose of this study was to consider whether visual field losses can be identified and quantified in the acute stages of stroke using an ipad based bed side perimetry app, The Melbourne Rapid Fields (MRF), developed to measure visual acuity and visual field integrity. The neuroanatomical site of lesion was also considered in relation to field deficits to evalute the clinical and radiographic imaging patterns with the patient’s visual acuity and visual field intergrity.